Short-term outcomes for open and laparoscopic midline incisional hernia repair: A randomized multicenter controlled trial: The prolove (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial
Rogmark P.,Skane University Hospital |
Petersson U.,Skane University Hospital |
Bringman S.,Karolinska Institutet |
Eklund A.,Sodertalje Hospital |
And 5 more authors.
Annals of Surgery | Year: 2013
Objective: The aim of the trial was to compare laparoscopic technique with open technique regarding short-term pain, quality of life (QoL), recovery, and complications. Background: Laparoscopic and open techniques for incisional hernia repair are recognized treatment options with pros and cons. Methods: Patients from 7 centers with a midline incisional hernia of a maximum width of 10 cm were randomized to either laparoscopic (LR) or open sublay (OR) mesh repair. Primary end point was pain at 3 weeks, measured as the bodily pain subscale of Short Form-36 (SF-36). Secondary end points were complications registered by type and severity (the Clavien-Dindo classification), movement restrictions, fatigue, time to full recovery, and QoL up to 8 weeks. Results: Patients were recruited between October 2005 and November 2009. Of 157 randomized patients, 133 received intervention: 64 LR and 69 OR. Measurements of pain did not differ, nor did movement restriction and postoperative fatigue. SF-36 subscales favored the LR group: physical function (P<0.001), role physical (P<0.012),mental health (P<0.022), and physical composite score (P < 0.009). Surgical site infections were 17 in the OR group compared with 1 in the LR group (P < 0.001). The severity of complications did not differ between the groups (P < 0.213). Conclusions: Postoperative pain or recovery at 3 weeks after repair of midline incisional hernias does not differ between LR and OR, but the LR results in better physical function and less surgical site infections than the OR does. Copyright © 2013 by Lippincott Williams and Wilkins.
Frobert O.,Orebro University |
Lagerqvist B.,Uppsala University |
Olivecrona G.K.,Lund University |
Omerovic E.,Sahlgrenska University Hospital |
And 18 more authors.
New England Journal of Medicine | Year: 2013
BACKGROUND: The clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) is uncertain. We aimed to evaluate whether thrombus aspiration reduces mortality. METHODS: We conducted a multicenter, prospective, randomized, controlled, open-label clinical trial, with enrollment of patients from the national comprehensive Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and end points evaluated through national registries. A total of 7244 patients with STEMI undergoing PCI were randomly assigned to manual thrombus aspiration followed by PCI or to PCI only. The primary end point was all-cause mortality at 30 days. RESULTS: No patients were lost to follow-up. Death from any cause occurred in 2.8% of the patients in the thrombus-aspiration group (103 of 3621), as compared with 3.0% in the PCI-only group (110 of 3623) (hazard ratio, 0.94; 95% confidence interval [CI], 0.72 to 1.22; P = 0.63). The rates of hospitalization for recurrent myocardial infarction at 30 days were 0.5% and 0.9% in the two groups, respectively (hazard ratio, 0.61; 95% CI, 0.34 to 1.07; P = 0.09), and the rates of stent thrombosis were 0.2% and 0.5%, respectively (hazard ratio, 0.47; 95% CI, 0.20 to 1.02; P = 0.06). There were no significant differences between the groups with respect to the rate of stroke or neurologic complications at the time of discharge (P = 0.87). The results were consistent across all major prespecified subgroups, including subgroups defined according to thrombus burden and coronary flow before PCI. CONCLUSIONS: Routine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI. Copyright © 2013 Massachusetts Medical Society.
Lundstrom K.-J.,Ostersunds Hospital |
Sandblom G.,Karolinska Institutet |
Smedberg S.,Helsingborg Hospital |
Nordin P.,Ostersunds Hospital |
Nordin P.,Umea University
Annals of Surgery | Year: 2012
Objective: This study aims to analyze and identify risk factors for postoperative complications and analyze the relative risk of reoperation for recurrence for respective complication. Background: The outcome of groin hernia surgery is evaluated mostly by comparing recurrence rates and long-term pain. The aim of this observational population-based registry study was to identify risk factors for postoperative complications and analyze the relative risk of reoperation for recurrence for respective complication. Methods: Using data from the nationwide Swedish Hernia Register between 1998 and 2009, 150,514 herniorrhaphies were analyzed with respect to postoperative complications occurring within 30 days of surgery. Results: Risk factors significantly affecting the rate of postoperative complications were laparoscopic repair (odds ratio [OR] 1.35, 95% confidence interval [CI] 1.24-1.47) and open preperitoneal techniques (OR: 1.31, 95% CI: 1.15-1.49), with open anterior mesh as reference category. Other significant risk factors were general (OR: 1.30, 95% CI: 1.23-1.37) and regional anesthesia (OR: 1.53, 95% CI: 1.43-1.63), with local anesthesia as reference category, emergency procedures (OR: 1.53, 95% CI: 1.43-1.63); recurrent hernia repair (OR: 1.39, 95% CI: 1.27-1.52); femoral hernia (OR: 1.30, 95% CI: 1.14-1.48); aged older than 65 years (OR: 1.26, 95% CI: 1.21-1.31); and duration of surgery exceeding 50 minutes (OR: 1.27, 95% CI: 1.22-1.33). Conclusions: Open anterior approach and surgery under local anesthesia are associated with less risk of postoperative complications. © 2012 Lippincott Williams & Wilkins.
Bergstrom L.,Gothenburg University |
Svensson P.,Helsingborg Hospital |
Hartelius L.,Gothenburg University
International Journal of Speech-Language Pathology | Year: 2014
This prospective, single-blinded study investigated the validity and reliability of cervical auscultation (CA) under two conditions; (1) CA-only, using isolated swallow-sound clips, and (2) CSE + CA, using extra clinical swallow examination (CSE) information such as patient case history, oromotor assessment, and the same swallow-sound clips as condition one. The two CA conditions were compared against a fibre-optic endoscopic evaluation of swallowing (FEES) reference test. Each CA condition consisted of 18 swallows samples compiled from 12 adult patients consecutively referred to the FEES clinic. Patients' swallow sounds were simultaneously recorded during FEES via a Littmann E3200 electronic stethoscope. These 18 swallow samples were sent to 13 experienced dysphagia clinicians recruited from the UK and Australia who were blinded to the FEES results. Samples were rated in terms of (1) if dysphagic, (2) if the patient was safe on consistency trialled, and (3) dysphagia severity. Sensitivity measures ranged from 83-95%, specificity measures from 50-92% across the conditions. Intra-rater agreement ranged from 69-97% total agreement. Inter-rater reliability for dysphagia severity showed substantial agreement (rs = 0.68 and 0.74). Results show good rater reliability for CA-trained speech-language pathologists. Sensitivity and specificity for both CA conditions in this study are comparable to and often better than other well-established CSE components. © 2014 The Speech Pathology Association of Australia Limited.
Rung L.,Helsingborg Hospital |
Lovestam-Adrian M.,Skane University Hospital
Clinical Ophthalmology | Year: 2013
Background: The purpose of this study was to evaluate the visual outcome and self-reported vision-targeted health status in patients treated with intravitreal ranibizumab for wet age-related macular degeneration (AMD). Methods: A total of 51 eyes from 50 patients aged 76 ± 7 years, with wet AMD not previously treated, were included in this prospective study. Best corrected visual acuity was examined using Early Treatment Diabetic Research Study charts and near vision reading. All patients underwent an ophthalmological examination, including fluorescein and indocyanine green angiography (occult cases) and optical coherence tomography. The Visual Function Questionnaire test was completed before and 37 ± 7 months after the start of intravitreal injections. Results: The patients received a mean number of 7.8 ± 5.0 (range 2-22) injections. One month after the third intravitreal injection, significant improvement was seen in both visual acuity (53 ± 14 to 61 ± 14 letter, P = 0.001) and near vision (17 ± 9 to 11 ± 8 points, P = 0.001). During follow-up, mean visual acuity decreased from 53 ± 14 to 44 ± 24 letters (P = 0.011), and near vision decreased from 17 ± 9 to 20 ± 11 points (P = 0.048). Despite visual impairment, the quality of life test revealed no significant decrease in mental health (P = 0.529) or ability to read a newspaper (P = 0.21), but a decrease in distance activities (reading street signs, steps, going to the theater) from 57 ± 27 to 46 ± 31 points (P = 0.007) was documented. Conclusion: Decreased visual acuity was related to a decrease in self-reported visual function for distance activities, while mental health items, such as worrying, were not influenced. © 2013 Rung and Lövestam-Adrian, publisher and licensee Dove Medical Press Ltd.